On February 11, 2019, the FDA announced that it will likely undertake a massive overhaul of the regulation of the dietary supplements. Congress passed the Dietary Supplement Health and Education ACT (DSHEA) in 1994 granting FDA an oversight of the dietary supplements. At the time, this only required minimal reporting and labeling from the manufacturers. Throughout the years, however, the dietary supplement industry has become a $40 billion market comprising approximately 80,000 products. With this growth, a number of serious health concerns have surfaced including, but not limited to, incomplete labeling, potentially unsafe ingredients, and fraudulent/misleading marketing efforts. Given these circumstances, FDA is making an effort to regulate the industry.
FDA commissioner, Scott Gottlieb, M.D., stated that he is “concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks…and [t]o continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products.” In this vein, on February 11, 2019, the FDA issued twelve Warning Letters and five Online Advisory Letters to manufacturers that were allegedly illegally marketing unapproved supplements, among which includes dietary supplements claiming to prevent or treat Alzheimer’s disease. In doing so, the FDA claimed that the products are no longer dietary supplements because they were claimed to cure or treat a medical condition, which would require the manufacturers to seek FDA review for safety and efficacy in order to obtain market approval.
Additionally, the FDA will launch a series of actions, which may include improved communication with the public regarding dietary supplement concerns, focusing on regulatory framework and flexibility to help promote safety and innovation, develop new enforcement strategies, engage public dialogue for feedback on supplements, and create an online watch list of specific ingredients the agency is concerned about.
In the meantime, manufacturers must be cognizant of their products, labeling requirements, and marketing strategy. Frier Levitt’s Life Science attorneys have extensive experience advising clients on labeling, advertising and promotion, adverse event reporting, product recalls, product liability, agency inspections and remediation of inspection findings, and responding to agency enforcement actions.
Contact Frier Levitt today to speak to an attorney about this and other current FDA policies and regulations.